Fracture of Distal Radius Clinical Trial
Official title:
Treatement of Extension Fractures of the Distal Radius : Prospective Randomized Postoperative Comparison Between Trans-styloid and Intrafical Pinning on the One Side and Volar Fixed-angle Plating on the Other Side.
Treatment of extension fractures of the distal radius : prospective randomized postoperative comparison between trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side.
Distal radius fractures are more and more numerous. Most of the time, the people concerned
are elderly or old with an osteoporotic bone, and an important dorsal metaphysal
comminution. The French reference treatment of the extension distal radius fracture, the
Kapandji method, turns out to be less and less performing to treat such complicated
fractures. At the moment, two points of view are in opposition in France. On the one side,
the point of view of those who are in favour of the treatment by intrafocal pinning: they
think they will be able to improve their technique if they add a trans-styloid pinning of
stabilisation. On the other side, those who are in favour of a treatment using a volar
fixed-angle plating.
The purpose of the study is to compare these two types of treatment by using a prospective
and randomized analysis.
The main judging criterion will lay on an X-ray assessment of the distal radius, we will try
to find a loss of reduction at tree month.
The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score) at 6
weeks, 3 months and 6 months, as well as on post-operative X-ray assessments in order to
compare post-operative reduction of the distal radius fracture.
All the patients taken to the emergency ward of Limoges Hospital, and suffering from an
extension distal radius fracture (intra or extra articular according to Kapandji
classification) will have the possibility to participate in this study, if they want to.
The patients will be X-rayed before and after the operation, they will have an
immobilization for 3 weeks. Then the cast will be removed, and new X-rays will be taken.
Then the patients will be allowed to perform their daily activities. A new follow-up control
will take place 6 week later, it will include a new series X-rays and functional scores. At
this point, people will be able to start physiotherapy. New functional scores and X-ray
assessments will still be taken 3 and 6 months later.
All the X-rays will be analyzed by an orthopaedist, a radiologist, and by a radiological
software.
- Fonctional scores (quickDASH and Herzberg score) at 6 weeks, 3 months and 6 months.
- X-ray assessment after the operation and at 3 weeks, 6 weeks, 3 months and 6 months.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment